Streetbeat News

Regulatory

TOVX

Theriva Biologics announced a positive review from the Data and Safety Monitoring Committee for its Phase 1b/2a trial of SYN-004 in preventing acute graft-versus-host-disease in transplant recipients. The study will proceed to enroll Cohort 3.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 12:03 pm

T

TMUS

VZ

European telecom companies, including Vodafone, Telefonica, and Orange, are considering legal action against SpaceX's Starlink if the FCC relaxes radio emission rules. They argue that such changes could harm terrestrial mobile networks. U.S. companies like AT&T and Verizon also express concerns. SpaceX seeks a waiver to ensure reliable communications, especially during emergencies, and has reached a milestone with its 7,000th satellite launch.

Portfolio Pulse from Rounak Jain

October 03, 2024 | 11:50 am

PIRS

Palvella Therapeutics, the merger partner of Pieris Pharmaceuticals, has received a grant of up to $2.6 million from the FDA's Office of Orphan Products Development. This grant will support the Phase 3 SELVA trial of QTORIN 3.9% Rapamycin Anhydrous Gel for treating Microcystic Lymphatic Malformations.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:42 am

ELAB

Elevai Labs has filed two patent applications for its lead candidate, EL-22, targeting muscle loss treatment in obese patients. The patents cover standalone and combination therapies with GLP-1 receptor agonists.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:38 am

DM

NNDM

Desktop Metal stockholders have approved a merger with Nano Dimension, with the transaction expected to close in Q4 2024 pending regulatory approvals. 60% of outstanding DM shares voted, with over 96% in favor.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:32 am

ZVIA

Zevia PBC has regained compliance with the New York Stock Exchange's minimum stock price continued listing standard, ensuring its continued listing on the exchange.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:10 am

RNA

Avidity Biosciences announced that the FDA has removed the partial clinical hold on Delpacibart Etedesiran (Del-Desiran/AOC 1001), an investigational treatment for Myotonic Dystrophy Type 1. This development allows the company to proceed with its clinical trials.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:06 am

IONS

Ionis Pharmaceuticals is set to present new three-year data from its Phase 2 open-label extension study and additional results from the Phase 3 OASIS and OASISplus studies of Donidalorsen for Hereditary Angioedema at the 2024 ACAAI Annual Scientific Meeting.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:06 am

ALDX

Aldeyra Therapeutics has resubmitted a New Drug Application to the FDA for its investigational drug, Reproxalap, aimed at treating dry eye disease. This marks a significant step in the drug's approval process.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 11:03 am

AZN

The FDA has accepted and granted priority review to AstraZeneca's supplemental new drug application for Calquence (Acalabrutinib) for previously untreated mantle cell lymphoma. The FDA action date is anticipated during Q1 of 2025.

Portfolio Pulse from Benzinga Newsdesk

October 03, 2024 | 9:33 am